Position Summary:

The Clinical Quality Assurance Director will play a lead role in the further development and management of the CQA program at Visterra. This will be done in accordance with applicable global regulatory requirements and Visterra business objectives. This role will oversee all GCP QA activities conducted by Visterra and Visterra’s Contract Research Organizations (CRO), and Investigator Sites to ensure third party suppliers are compliant with governing regulations and audit ready. The ideal candidate will have a strong working knowledge of relevant FDA, EU, ICH GMP, guidelines, and GCP regulations and experience working with CROs.

This role will report to the Head of Quality Assurance and will work closely with key stakeholders to ensure GCP compliance at Visterra and with Visterra’s contracted suppliers. This is a high visibility position that will play a key role in partnering with our parent company, Otsuka Pharmaceutical.

Duties and Responsibilities:

• Provide compliance support for activities at clinical sites including issue resolution, impact assessment and inspection readiness
• Provides input to clinical functions to ensure that clinical trial activities sponsored by or on behalf of Visterra are conducted by CROs in compliance with GCP regulations and internal requirements
• Provide internal audit support related to systems, documents and functions
• Prepare quality metrics for presentation to management
• Work directly with CROs and other external suppliers and collaborators, managing the chain of communication related to GCP compliance
• Attend cross-functional team meetings, provide guidance to different functional groups (including clinical and PV), based on interpretation of current regulations to ensure best practices using a risk-based approach
• Escalate issues of critical non-compliance and/or lack of urgency in remediation to senior Quality management
• Provide QA review of clinical protocols, amendments, Informed Consent Forms, Clinical Study Reports, Investigator Brochures and other relevant clinical documents
• Provide and/or assist in periodic GCP training to the Visterra staff, as necessary
• Assists in resolving compliance issues at clinical sites, clinical vendors, laboratories, and other suppliers by providing an assessment of the impact of any deficiencies and follow-up of CAPA implementation
• Implement CAPAs to address critical GCP QA issues
• Acts as GCP QA Study/Program lead
• Supports the implementation and maintenance of QA systems and SOPs for GCP compliance
• Support clinical quality oversight activities for multiple programs within Clinical Development
• Ensure Clinical Development activities are compliant with GCP, FDA, ICH, and other applicable regulations and guidelines and industry standards
• Review key safety, clinical and regulatory documents, such as DSUR, Protocol, IB, IND and NDA
• Foster Visterra core values when collaborating with cross functional teams and external partners
• Other duties and responsibilities as dictated by departmental and business needs
• Work to further develop and imbue a Quality culture

Education/Skills and Experience Requirements:

• Bachelor of Science degree in a scientific or healthcare related field
• Minimum of 10 years related experience in sponsor companies, CRO, or GCP roles
• Demonstrated experience with FDA or regulatory or health authority inspections
• Previous experience managing CROs and clinical suppliers required
• Audit certification preferred but not mandatory
• Expertise regarding GCP regulations and regulatory agency expectations and guidance
• Previous experience with Veeva QualityDocs
• Leadership, negotiation, and conflict management skills
• Excellent organizational and time management skills with a high level of attention to detail
• Strong interpersonal, organizational, and multi-tasking skills

Company

Visterra is a clinical stage biotechnology company committed to developing innova­tive biologic therapies (monoclonal antibodies and therapeutic muteins) for the treatment of kidney diseases, with an immuno-nephrology focus in drug development. Our proprietary technology platform enables the design and engineering of precision antibody or protein-based drug candidates to modulate key disease targets. We are de­veloping a robust pipeline of novel therapies for patients with unmet needs.

Visterra is a wholly owned subsidiary of Otsuka America, Inc., which is a U.S. holding company subsidiary of Otsuka Pharmaceutical Co., Ltd. of Japan. Visterra has approximately 100 employees, and is located in Waltham, Massachusetts.

Visterra provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.